NCT00098345CompletedPhase 2
An Open Label, Two Stage, Phase II Study to Evaluate the Efficacy and Tolerability of ZD6474 in Patients With Locally Advanced or Metastatic Hereditary Medullary Thyroid Carcinoma.
Genzyme, a Sanofi Company1 site in 1 country40 target enrollmentStarted: November 2004Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Objective Response Rate
Study Overview
Brief Summary
The purpose of this open label, two stage, phase II study is to evaluate the efficacy and tolerability of ZD6474 in patients with locally advanced or metastatic hereditary medullary thyroid carcinoma.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 130 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Locally advanced or hereditary medullary thyroid cancer
- •Signed informed consent
- •One or more measurable lesions
Exclusion Criteria
- •Brain metastases or spinal cord compression
- •Specific laboratory ranges
- •Specific heart problems
- •Prior chemotherapy and/or radiation therapy
- •Participation in other trials within 30 days
Arms & Interventions
Caprelsa (vandetanib) 300 mg
Experimental
Daily oral dose of Caprelsa (vandetanib) 300mg
Intervention: ZD6474 (vandetanib) (Drug)
Outcomes
Primary Outcomes
Objective Response Rate
Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) defined according to RECIST 1.0.
Secondary Outcomes
- Duration of Objective Response(Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.)
- Disease Control Rate(Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.)
- Biochemical Response Calcitonin (CTN)(Blood samples for analysis of CTN taken on Day 1 (every 3 hours for 24 hours), then a single sample on Day 5, weekly through the first 2 assessment periods, monthly (prior to amendment 7) and every 12 weeks (following amendments) until discontinuation)
- Symptomatic Response(Symptomatic diarrhea was assessed using stool frequency and consistency diaries. Baseline was established using the average of the 4 days immediately prior to first dose on Day 5. Diaries were completed every day for the first 6 months on study drug.)
- World Health Organisation (WHO) Performance Status(Performance status was assessed using the WHO criteria at baseline and because SD lasting for at least 24 weeks was used in the definition of disease control (in addition to confirmed objective response), WHO PS at 24 weeks was evaluated.)
- Progression Free Survival(Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.)
Investigators
Study Sites (1)
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